Large volume flexible container

ABSTRACT

A container ( 10 ) having a plurality of panels ( 12 - 18 ) joined together to form a sleeve ( 64 ). The panels ( 12 - 18 ) each have an end edge that cooperate to define an imaginary plane (P) at one end of the sleeve ( 64 ). The container ( 10 ) further has an end panel ( 20,22 ) connected to the panels ( 12 - 18 ) at the one end of the sleeve ( 64 ). The end panel ( 20,22 ) has at least one portion extending beyond the imaginary plane (P). The supporting box ( 100 ) is provided to support the container ( 10 ). A hanger system ( 150 ) is provided and is attached to the box ( 100 ). The hanger system ( 150 ) supports an upper portion of the container ( 10 ) within the box ( 100 ). The container ( 10 ) is also provided with a port closure ( 300 ) that provides both a sterile and gas permeable barrier.

TECHNICAL FIELD

[0001] The present invention relates, in general, to flexible containersand, more specifically, to large volume, three-dimensional flexiblecontainers.

BACKGROUND OF THE INVENTION

[0002] Containers used for the shipping, storing, and delivery ofliquids, such as therapeutic fluids or fluids used in other medicalapplications, are often fabricated from single-ply or multi-plypolymeric materials. The materials are typically in sheet form. Twosheets of these materials are placed in overlapping relation, and theoverlapping sheets are bonded at their peripheries to define a chamberor pouch for containing the fluids. These types of bags are typicallyreferred to as two-dimensional flexible containers, flat bags, or“pillow bags.” U.S. Pat. No. 4,968,624 issued to Bacehowski et al. andcommonly assigned to the assignee of the present application, BaxterInternational Inc. (“Bacehowski”), discloses a large volume,two-dimensional flexible container. These types of bags can reachvolumes as large as 600 liters.

[0003] While 600 liters is a significant volume for a flexiblecontainer, there has been an ever increasing need to provide flexiblecontainers of even greater volumes. This has lead to the development ofthree-dimensional flexible containers, sometimes referred to as “cubicbags.”

[0004] In the design and use of three-dimensional flexible containers ofsuch volumes, certain problems are encountered. The large volume ofliquid held by the containers exerts a hydraulic force against seams ofthe container, which in an unsupported state, might be sufficient tocause failure of the container. Indeed, containers this large, whenfilled with water or some other liquid, can weigh over 3000 pounds. Theforces associated with such liquid volumes can cause the container seamsto fail or rupture, therefore causing leaks in the container. The liquidheld by the container may not be a commodity solution but often asterile, custom formulated solution. Accordingly, even a very small leakcan be costly in that any seam rupture compromises sterility of theentire contents of the container. Also, a failure of a container seamcan cause literally hundreds of liters of liquid to escape from thecontainer. This is costly in replacing the lost liquid contents of thecontainer. Clean-up costs are also encountered.

[0005] These large volume, three-dimensional flexible containers are notintended to be free standing, but rather, are designed to be supportedby a rigid or semi-rigid support container commonly referred to as a boxor tank. The box can be made of various materials, commonly stainlesssteel. The stainless steel material is naturally an optical obstructionfrom seeing into the box. Typically, an operator has to look down intothe box from the top. The box may have an access door on a side wall toallow an operator to view the inside of the box. The door, however, isvery small in size and cannot provide a full view of the flexiblecontainer within the box. The side walls may have a series of smallsight openings to allow one determine the level of liquid in thecontainer. Similarly, however, these small sight openings do not allow afull view of the container within the box.

[0006] By necessity, the box and flexible container will have someinteraction. It is desirable for the filled flexible container totransfer the load and associated forces from the contained liquid to thebox, so that minimal loads (preferably zero) are carried by the flexiblecontainer material, especially the container seams. It is also desirablethat the container seams be fully supported to prevent containerfailures due to “creep,”which refers to the loss of seal integrity dueto low but continuous tensile forces.

[0007] Because of the size of the containers, it may be difficult toproperly align the container within the box. While initially properlyaligned, the flexible container may shift becoming misaligned during thecontainer filling process. If misaligned, the container can haveunwanted folds that do not properly expand when the bag is filled. Suchcontainer folds caused from misalignment can result in undue stress onthe container seams leading to container failure.

[0008] For example, as the container is filled with liquid, thecontainer inflates and conforms to the surrounding box. Ideally, thecontainer conforms as close to the inner walls of the box as possiblealthough pleating of the container can occur. At the appropriate time,the liquid is drained from the container wherein the containercollapses. If the container is unsupported, it will tend to collapse inhorizontal pleats. The pleats can trap liquid within the container thuspreventing the container from being fully drained. In some cases, oncethe container is drained, the container has served its purpose and isthen discarded. In other cases, the container may be refilled as part ofa larger process. In these instances, a horizontal pleating of thecontainer can restrict the desired realignment during the refillingprocess. This can result in poor orientation or loss of the effectivevolume of the container. It may also result in insufficient support ofthe container. Thus, it is also desirable to vertically support thecontainer within the box to optimize the draining and filling processes.Vertical support of the container within the box is particularlyimportant when filling the container a second time.

[0009] U.S. Pat. No. 5,988,422 is directed to a sachet forbio-pharmaceutical fluid products. While the sachet is athree-dimensional container, the container does not have optimal angularconstruction between sides of the container. This will impact how such acontainer can be supported in a surrounding box. Accordingly, optimalfilling, draining, and re-filling of the container cannot be achieved.

[0010] Some large volume flexible containers often employ a rigid orsemi-rigid tube used in the filling and draining of the container, oftenreferred to as a “dip tube.” The dip tube is attached to the top of thecontainer and extends downward to the bottom interior surface of thecontainer. The dip tube supports the center portion of the top panel ofthe container during draining much like a tent post. In thisconfiguration, the dip tube creates vertical pleats during draining ofthe container, and also allows a refilling deployment for the container.

[0011] The dip tube, however, has several disadvantages. First, the diptube cannot orient the distal vertical surfaces of the container if thecontainer foot print geometry is more complex than a circle. Inaddition, as the container is drained, the walls of the containerconverge towards the center essentially creating loads of compression onthe non-compliant dip tube. These compressive forces can cause severalproblems. The dip tube itself can buckle under these forces. The sealbetween the dip tube and the top of the container can be compromised. Abottom portion of the dip tube can also rupture the bottom of thecontainer. Using a dip tube structure also increases the cost thecontainer system. In addition, dip tubes are also often accompanied by acontainer vent to allow incoming air to displace fluid instead ofcollapsing the container material. Finally, the dip tube also providesanother potential mode of contamination ingress to the contents of thecontainer. Thus, there remains a need for a vertical support system forthe container within the box that addresses the needs of draining andrefilling without the added complexity of dip tubes and vents.

[0012] These large volume containers are also typically equipped withone or more ports equipped with a port closure for accessing the fluidwithin the container. The container may have the port in a bottom panelthat opens into the container. Oftentimes, the port closure includes atube having one end connected to the port. Because the container isoften used in medical and biotechnical applications, the port closuremust include means for maintaining the other free end of the tube freefrom contamination. In other words, the free end of the tube must beequipped with a sterile closure that prevents potential contaminantsfrom entering the tube and container. It is also desirable, however, toallow air to enter the container because it facilitates manipulation ofthe container during handling and installation.

[0013] There are two common approaches for providing a sterile closureat the free end of the tube. First, the free end of the tube can besealed shut. In this application, the tubing must be selected from athermoplastic material such as PVC or polyethylene that permits sealingof the material. This material can be heat sealed or sealed using othersealing energies such as radio frequency or ultrasonics. Using asilicone tube is desirable in the manufacturing process applicationswhere the container is used. For example, a pump can be connected to thetubing for long periods of time so that the fluid can be pumped from thecontainer. The silicone tubing also has the ability to withstand hightemperatures, especially when the end of the tube is sterilized usingsteam in place (S.I.P.) methodologies. One problem that exists in usinga sealed silicone tube, however, is that while providing a sterileclosure, it does not facilitate the free passage of gases. Gas transfer(venting) is desirable to facilitate manipulation of the containerduring handling and installation. In addition, to access a containerhaving a sealed tube, an operator must use a sharp implement such as aknife, blade or other cutting utensil to open the tube. This introducesan opportunity to contaminate the tube, and also poses a risk of injuryto the operator.

[0014] The second approach for providing a sterile closure at the freeend of the tube is to use a formed element such as an injection moldedpart or stainless steel coupling. The tubing is fitted to the part orcoupling, and then the part or coupling is covered with another matinginjection molded part or coupling. Similar to the sealed tube approach,such fittings provide a sterile closure but do not provide for gastransfer without loss of sterility. In addition, using injected moldedparts or stainless steel couplings is costly.

[0015] The present invention is provided to solve these and otherproblems.

SUMMARY OF THE INVENTION

[0016] The present invention relates to containers and, in particular,to large volume, three-dimensional flexible containers.

[0017] According to a first aspect of the invention, a container isprovided having a plurality of panels joined together to form a sleeve.The panels each have an end edge that cooperate to define an imaginaryplane at one end of the sleeve. The container further has an end panelconnected to the panels at the one end of the sleeve. The end panel hasat least one portion extending beyond the imaginary plane. According toanother aspect of the invention, the panels form a polygonal sleeve. Theportion of the end panel extends outwardly from the sleeve.Alternatively, the portion could extend inwardly towards the sleeve.

[0018] According to a further aspect of the invention, a large volumeflexible container capable of containing a fluid to be maintained understerile conditions is provided. The container has a first panel, asecond panel, a third panel, and a fourth panel connected together toform a generally cubic structure. The first panel has a central segmentadjacent an end segment. The central segment has a longitudinal edge andthe end segment has a tapered edge extending from the longitudinal edge.An angle is defined between the longitudinal edge and the tapered edge.The angle is in the range from about 135.01° to about 138°. In a mostpreferred embodiment, the angle is 136°. This angle is maintained whenthe panels of the container 10 are welded together.

[0019] According to a further aspect of the invention, a supportcontainer, or box, is provided for supporting the three-dimensionalflexible medical container filled with fluid. The box has a frame havinga top portion and a bottom portion. The frame has a plurality ofsidewalls connected together at their extremities forming a chambertherein. The frame further has a floor spaced from the bottom portion.The chamber is sized to receive the flexible medical container wherein abottom wall of the container is supported by the floor and sidewalls ofthe container are supported by sidewalls of the frame. Each sidewallsupports a generally transparent panel, preferably a polycarbonatepanel, such as Lexan™.

[0020] According to another aspect of the invention, a hanger system isprovided for providing vertical support of the container supportedwithin the box. A support member is connected to a top portion of thebox. A hanger is provided having a plurality of depending membersadapted to be connected to an end panel of the container. The hanger isconnected to the support member. In a preferred embodiment, the hangerincludes a first member and a second member connected togethersubstantially at their respective midportions to form an x-shapedmember. The depending members are pivotally connected to ends of thehanger members.

[0021] According to yet another aspect of the invention, a port closurefor the container is provided. The port closure provides a means forproviding a sterile and gas permeable barrier over the port. In oneembodiment, the port closure has a communication member having a firstend and a second end, the first end adapted to be in communication withthe container. A stop member is inserted into the second end of thecommunication member wherein the stop member is made from a porousmaterial. A cover member is provided and receives the second end of thecommunication member. The cover member is releasably secured to thecommunication member. In a preferred embodiment, the communicationmember is a tube made from a thermoplastic material. The stop member isa plug. An elastic band is wrapped about the pouch and the communicationmember releasably securing the cover member to the communication member.A tamper evident feature can also be incorporated into the port closure.

[0022] Other advantages and aspects of the present invention will becomeapparent upon reading the following description of the drawings anddetailed description of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

[0023]FIG. 1 is a perspective view of a medical fluid container of thepresent invention;

[0024]FIG. 2 is a perspective view of another medical fluid container ofthe present invention that is larger than the container shown in FIG. 1;

[0025]FIG. 3 is a perspective view of another medical fluid container ofthe present invention that is larger than the containers shown in FIGS.1 and 2, and shown in a vertical configuration;

[0026]FIG. 4 is a side elevation view of the container of FIG. 1;

[0027]FIG. 5 is a plan view of a panel of the container;

[0028]FIG. 6 is a plan view of a gusseted panel of the container;

[0029]FIG. 7 is a perspective view of an end panel of the container;

[0030]FIG. 8 is a perspective view of the container of the presentinvention in a generally folded configuration, a supporting box beingshown in phantom lines;

[0031]FIG. 9 is a perspective view of the container of FIG. 8 filledwith fluid during a filling process;

[0032]FIG. 10 is a perspective view of a box used to support thecontainer, the container being positioned in the box;

[0033]FIG. 11 is a front elevation view of a container of the presentinvention supported in a box and utilizing a container hanger system;

[0034]FIG. 12 is a side elevation view of the container of the presentinvention supported in the box utilizing the container hanger system;

[0035]FIG. 13 is a perspective view of the container hanger system ofthe present invention;

[0036]FIG. 14 is a top view of the container in the box of FIG. 13wherein the container is partially drained;

[0037]FIG. 15 is a schematic perspective view of an alternativeembodiment of the container hanger system of the present invention;

[0038]FIG. 16 is a schematic perspective view of another alternativeembodiment of the container system of the present invention;

[0039]FIGS. 17a-e are schematic views of a draining process of thecontainer supported by the container hanger system;

[0040]FIG. 18 is a plan view of a port closure used with the container;

[0041]FIG. 19 is a plan view of the port closure of FIG. 18 in analternative configuration;

[0042]FIG. 20 is a perspective view of a port closure connected to acontainer;

[0043]FIG. 21 is a perspective view of a container having multiple portswith a port closure connected at one port and an alternative portclosure connected at the other port;

[0044]FIG. 22 is a plan view of the container positioned in the box, thecontainer being partially filled;

[0045]FIG. 23 is a plan view of the container positioned in the box, thecontainer being substantially filled;

[0046]FIG. 24 is a partial enlarged view of a comer portion of acontainer positioned in a box;

[0047]FIG. 25 is a partial enlarged view of the container of the presentinvention in the box;

[0048]FIG. 26 is schematic perspective view of an alternative embodimentof the container hanger system of the present invention; and

[0049]FIG. 27 is a schematic perspective view of an alternativeembodiment of the container hanger system of the present invention.

DETAILED DESCRIPTION

[0050] While this invention is susceptible of embodiments in manydifferent forms, there is shown in the drawings and will herein bedescribed in detail a preferred embodiment of the invention with theunderstanding that the present disclosure is to be considered as anexemplification of the principles of the invention and is not intendedto limit the broad aspect of the invention to the embodimentsillustrated.

[0051] Referring to the drawings, FIG. 1 shows a container made inaccordance with the present invention generally referred to with thereference numeral 10. The container 10 is a three-dimensional containercapable of holding large amounts of fluid. The container 10 shown inFIG. 1 holds approximately 200 liters of fluid. The container 10,however, can be made in a variety of sizes. For example, FIG. 2 shows acontainer 10 sized to hold approximately 500 liters of fluid, and FIG. 3shows a container 10 sized to hold approximately 1500 liters of fluid.The container 10 has a unique configuration that reduces seam stress tothe container 10 caused by hydraulic forces generated from the fluidheld in the container 10.

[0052] As shown in FIG. 1, the container 10 is three-dimensional andgenerally has a rectangular shape having six sides, or sometimesreferred to as having four sides and two ends.

[0053] The container 10 is generally formed from four panels: a firstpanel 12 or top panel 12, a second panel 14 or bottom panel 14, a firstside gusseted panel 16 and a second side gusseted panel 18. These walls12-18 form four panels of the container and end portions of each wallcooperate to form the remaining two panels of the three-dimensionalcontainer 10, a first gusseted end panel 20 and a second gusseted endpanel 22. The individual walls will first be described and then theconnections between the walls will be described to show the structure ofthe container 10.

[0054]FIG. 5 shows a plan view of the first panel 12 or top panel 12. Itis understood that the second panel 14 or bottom panel 14 has a similarstructure and will not be individually described. The top panel 12generally has a central segment 24, a first end segment 26 and a secondend segment 28. A fold line FL represents an interface between thecentral segment 24 and the end segments 26,28. The end segments 26,28are folded and cooperate with end segments of the other panels tocooperatively form the end panels 20,22 as will be described in greaterdetail below.

[0055] As further shown in FIG. 5, the top panel 12 has a firstperipheral edge 30 and a second peripheral edge 32. Each peripheral edge30,32 has a longitudinal portion 34 at the central segment 24 and atapered portion 36 at the first end segment 26 and the second endsegment 28. At each end segment 26,28, the tapered portions 36 convergetoward one another but do not meet. Rather, the tapered portions 36 meetan end edge 38. As will be described in greater detail below, thelongitudinal portion 34 of the peripheral edge 30,32 meets the taperedportion 36 at an angle A. Similarly, an angle B exists between thetapered portion 36 and the fold line FL. Preferred measurements of theangles A and B will be described in greater detail below that optimizethe seam strength of the container 10. The top panel 12 can include aport 40 if desired. The bottom panel 14 could also have a port 40. Anadditional port 41 could also be provided (FIG. 1). It is understoodthat a port could be placed in any panel of the container 10.

[0056]FIG. 6 discloses a plan view of the first side gusseted panel 16.It is understood that the second side gusseted panel 18 has similarstructure and will not be separately described. The first side gussetedpanel 16 also has a gusset central segment 42, a first gusset endsegment 44 and a second gusset end segment 46. A fold line FL representsan interface between the gusset central segment 42 and the gusset endsegments 44,46. The gusset end segments 44,46 are folded and cooperatewith top and bottom panel 12,14 end segments 26,28 to cooperatively formthe end panels 20,22 as will be described in greater detail below.

[0057] As further shown in FIG. 6, the gusseted panel 16 has a firstperipheral edge 48 and a second peripheral edge 50. Each peripheral edge48,50 has a longitudinal portion 52 at the central segment 42 and atapered portion 54 at the first gusset end segment 44 and the secondgusset end segment 46. At each gusset end segment 44,46, the taperedportions 54 converge toward one another and meet at a point 56. As willbe disclosed, the gusseted panels 16,18 have a gusset fold GF atgenerally a center-line of the panel. The panels 16,18 fold inwardly atthe gusset fold GF.

[0058] In constructing the container 10 into a three-dimensional form,the peripheral edges of the panels 12-18 are generally joined bysuitable means known in the art, such as heat energies, RF energies,sonics or other sealing energies. The first and second gusseted sidepanels 16,18 are positioned to space the top panel 12 and the bottompanel 14. The peripheral edges of the top panel 12 are sealed torespective peripheral edges of the gusseted side panels 16,18 to formseams. Similarly, the peripheral edges of the bottom panel 14 are sealedto the opposite peripheral edges of the gusseted side panels 16,18.Specifically, for example, the peripheral edge 30 of the top panel 12 issealed to the peripheral edge 48 of the first gusset panel 16 whereinthe respective longitudinal portions 34,52 are sealed together to form aside seam 60 (FIG. 1), and the respective tapered portions 36,54 aresealed together to form end panel seams 62. In this fashion, and asshown in FIG. 1, the flexible container 10 is formed having a generallythree-dimensional rectangular shape. The central segments 24,42 of thepanels 12-18 form the sides of the container 10. The end segments 26,28of the first and second panels 12,14 and the end segments 44,46 of thegusseted side panels 16,18 cooperate to form the gusseted end panels20,22. In this configuration, the end segments 26,28,44,46 serve asconnecting members to form the end panels 20,22. The end segmentsconverge towards one another and can be configured to join at a point, aline or a polygon. In a preferred embodiment, the end segments convergeto a line. It is further understood that the container 10 can beconfigured into any number of N-sided polygonal shapes. It is furtherunderstood that the individual panels could be comprised of a pluralityof separate panels connected together to form the panels of thecontainer 10. This may be done, for example, in making a container 10even larger than the 1500 L container shown in FIG. 3.

[0059] In a typical construction of a three-dimensional container, angleB would be 45° creating the angle A (FIG. 5) between the longitudinalportion 34 and tapered portion 36 of the peripheral edge 30,32 of 135°.This would provide a construction such that the end panels 20,22 wouldbe generally perpendicular to the central segments 24,42 of the panels12-18. In the container 10 of the present invention, the angle A isincreased from 135° to within a range from about 135.01° to 138°. In amost preferred embodiment, the angle A is about 136°. By increasing thisangle, more material is provided in the gusseted end panels 20,22. Asshown in FIG. 4, this extra material allows the end panels 20,22 toextend outwardly from the central segments 24,42 providing a “pent roof”(See FIGS. 2, 4 and 7). As further shown in FIG. 4, the panels 12-18,when connected together form a sleeve 64. In the preferred embodiment,the sleeve 64 is in the form of a rectangular parallelpiped shape. Thepanels each have an end edge 63 that correspond to the end of thecentral segments 24,42 at the fold lines FL. The end edges 63 define animaginary plane P at the end of the sleeve 64. The end panel 20,22 hasat least one portion that extends beyond the imaginary plane P. In amost preferred embodiment, the end panel is contiguous with the sleeveand the entire end panel 20,22 extends beyond the imaginary plane P. Inthis configuration, the end edges of the sleeve 64 are represented bythe fold lines FL. With this extended configuration, when the container10 is filled with liquid, stresses on the end panel seams 62 arereduced. This also prevents additional stresses from being transferredto other portions of the container 10.

[0060]FIGS. 8 and 9 disclose a filling process for the container 10 suchas shown in FIGS. 1 and 2, e.g. a container 10 in a horizontalconfiguration. For initial clarity, the container 10 is shown out of thesupporting box (to be described) although it is understood that thecontainer 10 is filled with liquid after being positioned in the box.The container 10 is positioned horizontally with the bottom panel 14against the base of the box. The container 10 is flattened wherein thefirst and second gusseted side panels 16,18 can be folded inward to thecontainer 10 although they are shown extended in FIG. 8. The gussetedend panels 20,22 are folded over on top of the top panel 12 when thecontainer is in a supporting box. In this configuration, the containeris easily filled. As shown FIG. 9, as the container 10 is filled, thegusseted side panels 16,18 begin unfolding. Because each panel 16,18 hasa single horizontal fold GF, as opposed to vertical gusset folds, thereis less of a chance for the panels 16,18 to hang-up against the box andnot fully unfold. If the panels 16,18 hang-up against the box, itprevents the container 10 from being fully inflated, which can placeundue stress on the container seams during filling and transportation ofthe container 10. FIG. 9 shows the container 10 partially filled.

[0061]FIG. 2 discloses another container 10 that is designed to holdapproximately 500 liters. FIG. 3 discloses an even larger container 10designed to hold approximately 1500 liters. In containers 10 of the sizeshown in FIG. 3, it is sometimes desirable to configure the containersuch that gusseted end panels 20,22 are at the top and bottom of thecontainer 10. Containers of this configuration can be as much as 15 feetin height. This gives the container 10 a smaller footprint, which isdesirable so it can be carried on a standard pallet. A verticalfootprint also minimizes the floor space occupied by the container,which can be important in storing a large quantity of containers. Thecontainer 10 has a generally rectangular footprint which provides agreater overall volume than a generally cylindrical container of thesame height. It is understood that in a container 10 having a verticalconfiguration (FIG. 3), one of the end panels 20,22 may be referred toas a bottom panel such as end panel 20 shown in FIG. 3.

[0062] The container 10 of the present invention is not designed to beself-supporting, but is rather supported by a supporting container 100or rigid box 100. FIGS. 10-12 disclose the box 100 that supports thecontainer 10. The box 100 disclosed in FIGS. 10-12 is designed tosupport a container 10 in a vertical configuration such as shown in FIG.3 although it is understood that a box 100 can be configured to supporta container 10 in a horizontal configuration. The box has an outer framemade up of a plurality of frame members 102. The frame members 102 areconnected together to form a front wall 104, a rear wall 106 and twosidewalls 108,110. The walls 104-110 are connected together to form achamber having a generally square or rectangular cross-section. Eachwall 104-110 has vertical members 112 and cross-members 114 to addrigidity to the walls. A bottom portion of the vertical members 112 areadapted to rest on a supporting floor surface. The frame members 102 ofeach wall 104-110 support a panel 113. In a most preferred embodiment,the panels are clear polycarbonate panels such as Lexan™ panels. Theframe members 102 of the walls 104-110 and the panels 113 cooperate andare referred to as side panels of the box 100. The front wall 104 has adoor 105 that is removably connected to the front wall 104. The door 105allows access to the inside of the box 100 prior to filling thecontainer 10 placed in the box 100. The box 110 further has a bottomwall 116 that is positioned inward from the bottom portions of thevertical members 112 so that the bottom wall 116 is slightly raised fromthe supporting floor surface. The bottom wall 116 has a first opening118 and a second opening 120. These openings 118,120 will correspond tothe ports 40,41 located on the container 10. The openings 118,120 helpto properly locate the container 10 within the box 100. The top portionof the box 100 is open and is designed to receive the flexible container10. When the flexible container 10 is inserted into the box 100, adischarge port and hose connected to the container (See e.g., FIG. 20)is fed through the first opening 118. The container 10 will also have asecond port 41, which may be closed, that is inserted into the secondopening 120 and assists in further properly locating the container 10within the box 100. The container 10 is positioned such that the bottompanel 20 of the container 10 is supported by the bottom wall 116 and thecorners of the bottom panel 20 of the container 10 are positionedsubstantially at the corners of the bottom wall 116. The container 10 isthen connected to the hanger system to be described and then is ready tobe filled.

[0063] FIGS. 10-17 disclose a hanger system 150 used in accordance withthe present invention. The hanger system 150 is utilized to support theempty upper portion of the container 10 to optimize filling and drainingof the container 10. For clarity, only a portion of the box 100 is shownin FIGS. 13, 15 and 16. The hanger system 150 generally includes ahanger 152, a support member 154, a cable 156 and a counterweight system158.

[0064] As shown in FIG. 13, the hanger 150 has a first member 160 and asecond member 162 connected together substantially at their respectivemidportions to form an x-shaped member. The angles between the members160,162 could vary as desired. In one preferred embodiment, an angle Ais approximately 70° and an angle B is approximately 110°. The firstmember 160 has a first end 164 and a second end 166. The second member162 has a first end 168 and a second end 170. The hanger 150 serves as aspreader member wherein the ends of the members 160,162 spread out overthe end panel or top panel 22 of the flexible container 10. Each end164-170 has a depending member 172 extending downwardly therefrom. In apreferred embodiment, the depending members 172 are pivotally connectedto the first member 160 and second member 162. The pivotal connectionprovides benefits in the draining process and the filling process aswill be described below. The depending members 172 each have aprotrusion that is received in an eyelet 173 connected to the container10 to hang the container 10 from the hanger 152. In a preferredembodiment, and as shown in FIG. 7, the eyelets 173 are located along adiagonal seam between 35% and 65% of the length of the seam as measuredfrom an outer corner C of the filled container 10. It is understood thatthe hanger members 160,162 can have different lengths to accommodatecontainers 10 of different sizes. The hanger 152 provides aspider-shaped support configuration that spreads out the container 10 sothat the container 10 fills up with fluid with a minimum amount ofpleating against the Lexan™ panels 113 of the side panels of the box100. It is further understood that the number of members and dependingmembers of the hanger 152 could vary depending on the size of thecontainer 10 and the desired hanging configuration.

[0065] As shown in FIGS. 11 and 12, the support member 154 is generallyan overhead support bracket 154. The support bracket 154 has a firstpost 174 and a second post 176 connected by a cross rail 178. The firstpost 174 is connected to one side of the top portion of the box 100 andthe second post 176 is connected to an opposite side of the top portionof the box 100. Thus, the cross-rail 178 spans over the open top portionof the box 100. In its simplest form, the container 10 is adapted to behung from the hanger 152 by the cable 156 that is connected between thehanger 156 and the support member 154.

[0066] The counterweight system 158 generally includes a first pulley180, a second pulley 182, and a counterweight 184. The counterweightsystem 158 allows tension adjustment to the upper portion of thecontainer 10. The first pulley 180 is connected to the cross rail 178and the second pulley 182 is connected to a side of the box 100. Thehanger system 150 is connected such that a first end 186 of the cable156 is connected to the hanger 152 and a second end 188 of the cable 156is connected to the counterweight 184. The counterweight 184 issuspended outside and adjacent to the box 100. The cable 156 passes overthe first pulley 180 and the second pulley 182. The hanger system 150provides an upward biasing force to the top portion of the flexiblecontainer 10. By changing the weight of the counterweight 184, tensionon the container 10 can be adjusted, in keeping with the volume of thecontainer 10.

[0067]FIGS. 15 and 16 disclose alternative embodiments of hanger systemsfor the container 10. FIG. 15 discloses a hanger system 200 having ahanger 202. The hanger 202 has a plurality of cables 204 that dependfrom the hanger 202 and are connected to the container 10. The hanger202 acts to spread the cables 204 to prevent tangling. The hanger system200 is hung from the support member 154 and has a counterweight system158. FIG. 16 discloses another hanger system 210. The hanger system 210has a first flexible member 212 and a second flexible member 214connected together substantially at their respective midportions. Theends of the flexible members 212,214 are adapted to be connected to thecontainer 10. The flexible members 212,214 have a curved configuration.The hanger system 210 would be hung from the support member 154 andwould also utilize the counterweight system 158. When the container 10is initially hung, the members 212,214 bend towards a downward U-shape.During the filling of the container 10, the members 212,214 wouldstraighten as the top panel of the container transitioned from avertical configuration to a horizontal configuration. It is understoodthat the hangers of the hanger system of the present invention could bemodified to include a additional members such as to be employed with anyN-sided polygon foot print with at least one connection per corner.

[0068]FIGS. 26 and 27 disclose additional alternative embodiments ofhanger systems for the container 10. FIG. 26 discloses a spring assembly400 that is mounted to a top portion of the supporting box 100, shownschematically. The spring assembly 400 has a rod 402 having cords 404extending from and connected to the rod 402. The rod 402 is rotatablybiased to wind the cords on the rod 402. This provides an upward biasingforce on the container 10. As shown in FIG. 27, two spring assemblies400 can also be provided. It is further understood that additionalspring assemblies 400 could be employed as desired.

[0069] It is further understood that hanger systems having differentconfigurations to provide an upward biasing force on the container 10are possible. For example, springs could be employed between the box 100and container 10. Other elastic members could be configured to apply anupward force on the container. Another box could be utilized andconnected to the box 100 in a coaxial fashion. A cylinder assembly couldbe connected between the two coaxial boxes to provide an upward biasingforce or tension on an upper portion of the container 10.

[0070] Once the container 10 is placed in the box 100 and hung using thehanger system 150, the container 10 can be filled. Fluid is pumpedusing, for example a peristaltic pump (not shown) that can be attachedto a side portion of the box 100. The pump will pump fluid through theport hose attached to the port 40 on the bottom panel 20 of thecontainer 10 (FIG. 3). The hanging system 150 helps to suspend thecontainer 10 uniformly within the box 100 such that there is a minimumamount of pleating of the container 10 against the side panels of thebox 100. Also, the hanger system 150 permits full deployment of thebottom panel 20 of the container 10 along the contours of the bottomfloor 116 of the box 100. As the container 10 continues to be filled,the sidewalls of the container 10 deploy substantially uniformly againstthe side panels of the box 100. As the container 10 nears its fullvolume, the pivoting depending members 172 pivot as the top panel 22 ofthe container 10 transitions from a generally vertical configuration toa substantially horizontal configuration.

[0071] Once filled, the container 10 is ready to be attached, forexample, as part of a subsequent process. Such process may require thecontainer 10 to be drained to deliver the fluid to another location forfurther processing. In this situation, the pump will pump fluid from thecontainer 10. As fluid is pumped from the container 10, thecounterweight 184 maintains an upwardly biasing force on the container10 to assist in the draining process. FIGS. 17a-17 e schematicallydisclose a draining process of a flexible container 10 in the verticalconfiguration being vertically supported by the hanger system 150. Asshown in FIGS. 17a-17 c, the flexible container 10 pulls away from thebox 100 as the container 10 is drained. The container 10 beginscollapsing at the outermost comers of the container 10 because of thelocation of the connecting points with the depending members 172. Theresulting shape is peaked with the volume reduction of the emptyingcontainer 10 defined by inward peaked folding pleats. As shown in FIGS.17d and 17 e, the defining shape is tent-like with the formation ofvertical wrinkles 185. The vertical wrinkles 185 are defined between thehanger connection points and the draining level of the fluid within thecontainer 10. Vertical wrinkles are more desirable than horizontalpleats as vertical wrinkles will allow greater deployment of thecontainer 10 within the box 100 during a refilling process. As shown inFIG. 17e, as the fluid is pumped out, and with the comers of the bottompanel of the container 10 placed appropriately at the comers of the box100, the bottom panel of the container 10 is sucked convex upward awayfrom the intermediate floor of the box 100 by the evacuating action ofthe draining pump. This defines drainage points on the container 10allowing fluid to run downwardly on this surface to the port 40. Asshown in FIG. 14, the depending members 172 pivot inwardly as the toppanel shifts from a substantially horizontal configuration to a morevertical configuration.

[0072] During a refilling process, the pump pumps fluid back into thecontainer through the same port 40 at the bottom panel 20 of thecontainer 10. The convex upward configuration of the bottom panel 20 isre-contoured to the bottom floor 116 of the box 100 by the weight of thefluid. The fluid also then refills the lower corners of the bottom panel20 at the junction of the vertical wrinkles 185 on the side panels ofthe container 10. During the refilling of the container 10, the verticalwrinkles 185 are once again defined by the level of the fluid pushingthe material towards the comers of the box 100 and by the upwardconnection of the hanger 152. Because of the configuration of the hanger152 and its connection to the top panel of the container 10, the cornersof the container 10, as the container 10 is filled, tend to assist oneanother in positioned themselves at the comers of the box 100. Becausethe wrinkles 185 are in a vertical configuration, the wrinkles 185 donot get trapped against the side panels of the box 100 as a horizontalfold would get trapped. The vertical wrinkles 185 rather open and deployagainst the side panels of the box 100.

[0073] The hanger system 150 provides several advantages. The hangersystem 150 permits the use of large volume flexible containers having asingle port for use in applications that require filling, draining andthen refilling without the additional expense and hazards that may beassociated with flexible containers containing dip tube or vent designfeatures. The hanger system 150 also permits complete collapse of thefilled container 10 during the draining process without having to admitair into the container 10, thereby maintaining a closed system. Thesystem 150 further provides support for refill deployment of thecontainer 10 which minimizes undesirable pleating of the container 10.The system 150 forces the collapse of the container during draining tooccur with predominately vertical wrinkles as opposed to horizontalcreases that can prevent redeployment of the container 10 duringrefilling. This vertical collapsing configuration greatly improves thedrainage performance of the container as the bottom panel of thecontainer 10 is sucked convex upward defining lower drainage points onthe container 10.

[0074]FIGS. 22 and 23 disclose a further aspect of the invention. Theflexible container 10 is sized to be larger than the box 100. In thisconfiguration, the amount of stress on the container seams is minimizedif the container 10, for example, does not become optimally alignedwithin the box wherein the four comers of the container aresubstantially adjacent the four comers of the box. FIG. 22 discloses aschematic plan view of the container 10 within the box 100. Thecontainer 10 is only partially filled with fluid. The panels of thecontainer are defined by a container width CW and a container depth CD.The panels of the container 10 cooperate to define a first perimeter P1,i.e. P1=2* (CW+CD). The side panels of the box are defined by a boxwidth BW and a box depth BD. The panels of the box cooperate to define asecond perimeter P2, i.e. P2=2* (BW+BD). The panels of the container 10are sized such that the first perimeter P1 is larger than the secondperimeter P2. This allows for some “play” with respect to the container10 within the box 100 and will provide a certain amount of wrinkles inthe container 10 preferably at the comers of the container 10 and box100. In a preferred embodiment, the container 10 is sized with respectto the box 100 so that the first perimeter P1 is about 2% to about 10%larger than the second perimeter P2 of the box 100. As shown in FIG. 23,when the container 10 is substantially filled with fluid within the box100, wrinkles are formed in the container 10 at or near the corners. Ifthe container 10 was sized substantially identically to the box 100,corners of the container 10 could pull away from the corners as shown inFIG. 24 thus putting more stress on the container 10. As shown in FIG.25, a larger sized container 10 alleviates these potential problemswherein comers of the container 10 are optimally supported at corners ofthe box 100.

[0075] FIGS. 18-21 disclose a port closure 300 according to the presentinvention designed to provide a unique closure for the port 40 of thecontainer 10. The port closure 300 provides both a sterile and gaspermeable barrier. The port closure 300 generally includes acommunication member 302, a stop member 304, a cover member 306 and aband 308. The communication member 302 is typically in the form of atube. The tube 302 is typically made from an elastomeric material suchas silicone. The size of the tube can vary depending on the particularapplication. In one preferred embodiment, a ¾ in. tube is used. The tube302 has a first end and a second end, and the length of the tube isdetermined by the desired application. The stop member is typically inthe form of a plug 304. The plug 304 is typically cylindrical andselected from material that is porous but has hydrophobic propertiessuch that it allows gases such as air to pass through the plug 304 butprevents fluid from passing through the plug 304. In one preferredembodiment, the plug 304 is made from a porous plastic material such aspolyethylene. Polytetrafluouroethylene material could also be used.Other materials are also possible and materials can be used after beingtreated to possess hydrophobic properties. The pore size of the materialis sized so that it is capable of providing a gas permeable, sterilebarrier. In a most preferred embodiment, the plug is acommercially-available Porex® hydrophobic material. The plug 304 isgenerally about 1 inch in length and has a diameter sized such that itwill form an interference fit when inserted into an end of the tube 302.As further shown in FIGS. 18-20, the cover member 306 has a first member310 and a second member 312. The members 310,312 can be made fromcellophane or paper. In addition, one member can be paper and one membercan be cellophane. As explained in greater detail below, the members310,312 are sealed to one another to form a two-ply, peelable pouchhaving an opening to receive the second end of the tube 302. The band308 is typically also made from elastic material such as silicone andcan be cut from tube stock identical to the tube used in the portclosure 300.

[0076] As further shown in FIG. 20, in constructing and connecting theport closure 300 to the container 10, the tube 302 is first cut to thedesired length, e.g. 6-30 feet of tubing. A first end 314 of the tube302 is inserted over the port 40 on the container 10 to form aninterference fit. A cable tie 316 can be placed around the first end 314of the tube 302 when installed on the port 40 to more securely connectthe tube 302 over the port 40. After tightening, the cable tie 316 istrimmed accordingly. The plug 304 is cut into a one inch length from thedesired plug stock. As shown in FIGS. 18 and 19, the plug 304 is theninserted into a second end 318 of the tube 302. A portion of the plug304 extends from the second end of the tube 302 to allow the operator tograsp the plug 304 on removal from the tube 302. The first and secondmembers 310,312 of the cover 306 are sealed to one another but leavingone open end 320 (FIG. 20) to form a pouch 322. The cover 306 is thenplaced over the second end 318 of the tube 302 and plug 304. The band308 is then placed around the cover 306 and the tube 302 to secure thecover 306 to the tube 302. Because the elastic band 308 is cut from tubestock identical to the tube 302, when the band 308 is placed around thetube 302, it provides a radially compressive force on the cover 306against the tube 302. The cover 306 provides a dustcover so that if thesecond end 318 of the tube 302 is inadvertently dropped on the floor orotherwise touch contaminated, the porous plug 304 and tube end 318remains clean and sterile. If a tamper evident feature is desired, thecover member 306 may be permanently affixed to the second end 318 of thetube 302 with a non-removable accessory such as a shrink band 309 (FIG.19). In addition, as shown in FIG. 18, the cover 306 could be directlyheat sealed to the tube 302 thus providing a tamper evident feature.

[0077] There are two general methods to access the plug 304 at thesecond end 318 of the tube 302. As shown in FIG. 18, top edges 324 ofthe first and second members 310,312 can be peeled apart to open thecover 306. Alternatively as shown in FIG. 19, the band 308 can be rolleddown the tube 302 and the cover 306 pulled away from the second end 318of the tube 302. In either case, once the cover 306 is removed, the plug304 can also be removed wherein the fluid can either be drained orpumped from the container 10.

[0078] In certain instances, a container may have a plurality of ports,e.g. a fill port, a drain port and a vent port. FIG. 21 discloses acontainer 10 having an additional port 330 closed by a vent closure 332.The vent closure 332 is similar to the port closure 300 described above.The vent closure 332 has a short silicon tube 334 having one endconnected to the additional port 330. A vent plug 336 made from the samematerial as the port closure plug 304 is inserted into the free end ofthe tube 334. The vent plug 336 allows gases to pass therethrough toequalize pressure inside the container 10 to the pressure outside thecontainer 10. The vent plug 336 enables complete filling of thecontainer 10 and attendant reduction of headspace (i.e., the space ofthe fluid level and the top of the container). This is an advantage in astationary container application because uncontrolled headspace cancause an alteration in the gas concentrations in the fluid, thuspermitting a shift in the pH of the fluid. In a container 10 that is tobe transported, headspace is a particularly critical issue, becauseheadspace will allow sloshing of the fluid during shipping. Such fluidmovement can cause degradation of proteins in the fluid due todenaturation (foaming), as well as compromising the container itself dueto repeated mechanical stresses (flex cracking).

[0079] As further shown in FIG. 21, if desired, a valve 338 can bepositioned within the tube 334, or communication member, in between thefirst end and the second end. The valve 338, such as a stopcock valve orother suitable valve, can be open or closed to allow or prevent ventingof the container 10 as desired. For example, the valve 338 can be openedto vent the container 10 during the later stages of filling. Conversely,the valve 338 can be closed such as during shipping and draining.

[0080] The port closure 300 of the present invention provides numerousadvantages, namely providing a sterile closure but still havinggas-permeable properties. The sterile barrier prevents contamination.The permeable property of the closure 300 equalizes the internalpressure within the tube 302, and therefore the container 10 that is incommunication with the tube 302, and the external pressure around thecontainer 10. Pressure equalization allows sterile air to enter thecontainer 10, which facilitates manipulation of the container 10 duringhandling and installation. For example, pressure equalization allows thelarge, flexible, collapsible container 10 to be easily manipulated whileempty, without the risk of introducing non-sterile air into thecontainer 10. It is essential to have air in the container 10 duringhandling and installation, because the air acts as a lubricant allowingthe container panels to move independently. However, having air in thecontainer 10 during sterilization and shipping contributes to containerbulk. Container bulk is undesirable and attempted to be minimized to thegreatest extent possible. Thus, it is desirable to be able to ship thecontainer 10 filled with fluid but with as little air as possible, andthen to allow air to enter the container 10 without breaching sterility.The sterile, gas permeable port closure provides these advantages. Ifthe second end 318 of the tube 302 is accidently dropped or introducedto contaminants, the cover member 306 maintains the second end 318 ofthe tube 302 and plug 304 sterile. In addition, the port closure 300does not require injected molded ports or stainless steel couplings,thus providing cost savings. Furthermore, by using an interference fitbetween the tube 302 and plug 304, no solvents are needed to connect theplug 304 to the tube 302, therefore reducing the amount of leachablesinto the container 10.

[0081] It is understood that, given the above description of theembodiments of the invention, various modifications may be made by oneskilled in the art. Such modifications are intended to be encompassed bythe claims below.

What is claimed is:
 1. A flexible container comprising: a plurality ofpanels joined together to form a sleeve, the panels each having an endedge that cooperate to define an imaginary plane at one end of thesleeve; and an end panel connected to the panels at the one end of thesleeve, the end panel having at least one portion extending beyond theimaginary plane.
 2. The container of claim 1 wherein the panels form apolygonal sleeve.
 3. The container of claim 1 wherein the panels eachhave a second end edge that cooperate to define a second imaginary planeat another end of the sleeve, the container further comprising a secondend panel connected to the panels at the other end of the sleeve, thesecond end panel having at least one portion extending beyond the secondimaginary plane.
 4. The container of claim 1 wherein the portion extendsoutwardly from the sleeve.
 5. The container of claim 1 wherein theportion extends inwardly towards the sleeve.
 6. The container of claim 1wherein the plurality of panels comprises four panels cooperativelyforming a sleeve having a generally rectangular cross-section.
 7. Thecontainer of claim 6 wherein two opposing panels are gusseted panels. 8.The container of claim 7 wherein the gusseted panels have a gusset fold.9. The container of claim 1 wherein the end panel is contiguous with theplurality of panels.
 10. The container of claim 1 wherein the end panelcomprises a plurality of connecting members.
 11. The container of claim10 wherein the connecting members converge to a point.
 12. The containerof claim 10 wherein the connecting members converge to a line.
 13. Thecontainer of claim 10 wherein the connecting members converge to apolygon.
 14. The container of claim 1 wherein one of the panels has aport.
 15. The container of claim 1 wherein the port has a port closureconnected thereto.
 16. The container of claim 15 wherein the portclosure comprises: a tube having a first end and a second end, the firstend adapted to be connected to the port; a plug inserted into the secondend of the tube, the plug being made from a gas permeable porousmaterial; a cover having a first member and a second member, the secondend of the tube being positioned between the members, the members beingsealed together at their respective peripheral edges; and an elasticband wrapped around the cover and tube.
 17. A flexible containercomprising: a plurality of panels joined together to form a sleeve, thepanels each having an end edge that cooperate to define an imaginaryplane at one end of the sleeve; and an end panel connected to the panelsat the one end of the sleeve, the end panel having a plurality ofconverging surfaces, the surfaces having at least one portion extendingbeyond the imaginary plane.
 18. The container of claim 17 wherein theconverging surfaces extend outwardly from the sleeve.
 19. The containerof claim 17 wherein the converging surfaces extend inwardly towards thesleeve.
 20. The container of claim 17 wherein the panels each have asecond end edge that cooperate to define a second imaginary plane atanother end of the sleeve, the container further comprising a second endpanel connected to the panels at the other end of the sleeve, the secondend panel having a plurality of converging surfaces, the surfaces havingat least one portion extending beyond the second imaginary plane.
 21. Alarge volume flexible container capable of containing a fluid to bemaintained under sterile conditions comprising: a first panel, a secondpanel, a third panel, and a fourth panel connected together to form agenerally cubic structure, the first panel having a central segmentadjacent an end segment, the central segment having a longitudinal edgeand the end segment having a tapered edge extending from thelongitudinal edge, an angle being defined between the longitudinal edgeand the tapered edge, the angle being in the range from about 135.01° toabout 138°.
 22. The container of claim 21 wherein the angle is in therange from about 135.5° to about 136.5°.
 23. The container of claim 21wherein the angle is 136°.